FDA Adverse Event
Injury
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 3935526
·
Received June 23, 2014
Report
- Report Number
- 3007981285-2014-01511
- Event Type
- Injury
- Date Received
- June 23, 2014
- Date of Event
- May 22, 2014
- Report Date
- May 22, 2014
- Manufacturer
- TANDEM DIABETES CARE INC.
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT RETURNING FOR EVALUATION. ATTEMPTS HAVE BEEN MADE TO OBTAIN ALL EVENT INFORMATION. SHOULD NEW INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION INDICATES THE CUSTOMER IS DOING FINE.
Description of Event or Problem · 1
RECEIVED INFORMATION REGARDING AIR BUBBLES IN THE PATIENT LINE (PIGTAIL) AND LUER LOCK. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 364912 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE INC. | 004628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Other |